Hepatocellular CarcinomaPhase 3NCT05711823
Aprepitant Plus Granisetron and Dexamethasone for the Prevention of Vomiting in Patients With HAIC Therapy for HCC
A Phase 3 study testing Aprepitant in combination with granisetron and dexamethasone and Granisetron and dexamethasone in people with Hepatocellular Carcinoma, run by Guangxi Medical University.
Trial summary
This study aims to evaluate the safety and efficacy of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in the prevention of nausea and vomiting in patients with hepatocellular carcinoma (HCC) receiving hepatic arterial infusion chemotherapy (HAIC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Aprepitant in combination with granisetron and dexamethasone and Granisetron and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old;
- The patient is diagnosed with hepatocellular carcinoma according to the clinical diagnostic criteria of the Guideline for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) issued by the Health Commission of the People's Republic of China or confirmed by histopathology;
- ECOG performance score 0 or 1;
- Child-Pugh score of 5-7 (liver function);
- Receiving hepatic arterial infusion chemotherapy treatment;
- Expected survival time ≥6 months;
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- Hematological indexes should meet the following conditions: hemoglobin ≥90 g/L; Absolute neutrophil count ≥1.5×10^9/L; Platelet ≥75×10^9/L; Total bilirubin ≤1.5×ULN; ALT≤3×ULN; AST≤3 x ULN; Alkaline phosphatase (AKP) ≤2.5×ULN; Serum albumin ≥28 g/L; Serum creatinine ≤1.5×ULN;
- Urine protein <2+ or 24h urine protein quantity < 1.0g;
- For women of childbearing age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) are required during the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days prior to study inclusion; Male patients with fertile partners should use effective contraception during the study period and for 120 days after the study ends.
Who cannot join
- Received systematic chemotherapy in the past;
- The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);
- Active infection, or body temperature ≥ 38.5℃ or white blood cell count > 15 x 10^9/L 7 days before enrollment;
- Complications of arterial or venous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary infarction, etc. within 6 months;
- Those who have a history of alcohol or psychotropic drug abuse and cannot quit or have mental disorders;
- Pregnant or lactating women;
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- being treated with immunosuppressants or glucocorticoids (>10mg prednisone equal dose per day) within 2 weeks;
- Previous history of motion sickness, or combined with hepatic encephalopathy or brain metastases;
- Uncontrolled heart disease or symptoms (including but not limited to grade II or above heart function, unstable angina, myocardial infarction in the past 1 year, supraventricular or ventricular arrhythmias requiring treatment or intervention)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: ApRepitant in Combination With Granisetron and Dexamethasone versUs Granisetron and dexamEthasone for the Prevention of Vomiting in Patients With HAIC Therapy for Hepatocellular Carcinoma: a Randomized Controlled Study (ARGUE)
This study aims to evaluate the safety and efficacy of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in the prevention of nausea and vomiting in patients with hepatocellular carcinoma (HCC) receiving hepatic arterial infusion chemotherapy (HAIC).
Read the detailed description
FOLFOX regimen include oxaliplatin and 5-Fu. Oxaliplatin has a moderate emetic potential and 5-Fu has a low emetic potential according to European guideline for the prevention of nausea and vomiting caused by chemotherapy and radiotherapy. The Guideline recommend that patients receiving moderately emetogenic chemotherapy receive a three-drug regimen of 5-HT3, dexamethasone, and NK1-RA (aprepitant, fosaprepitant, netupitant or rolapitant). However, HAIC treatment is not through peripheral or central venous infusion of chemotherapy drugs as in other cancers, but through hepatic artery infusion of chemotherapy drugs. Chemotherapy drugs are mainly concentrated in the liver and belong to local chemotherapy, rather than systemic chemotherapy through the venous system. Therefore, although the HAIC regimen includes oxaliplatin and 5-Fu, two chemotherapeutic drugs that may cause vomiting, the literature on whether three-drug regimen is also needed to prevent vomiting has been less publicly reported. In order to further determine whether three-drug regimen is necessary, this project intends to conduct a multi-center, randomized, controlled trial to evaluate the efficacy and safety of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in preventing nausea and vomiting in HCC patients receiving HAIC treatment. The results of this project will provide a reference for improving the quality of life of HCC patients during HAIC treatment, the compliance of follow-up treatment and saving medical resources.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Aprepitant in combination with granisetron and dexamethasone, Granisetron and dexamethasone
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprepitant in combination with granisetron and dexamethasoneDrug
Patients with unresectable hepatocellular carcinoma will receive aprepitant in combination with granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.
Granisetron and dexamethasoneDrug
Patients with unresectable hepatocellular carcinoma will receive granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant in combination with granisetron and dexamethasone | Experimental | Patients with unresectable hepatocellular carcinoma will receive aprepitant in combination with granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy. Receives: Drug: Aprepitant in combination with granisetron and dexamethasone |
| granisetron and dexamethasone | Active comparator | Patients with unresectable hepatocellular carcinoma will receive granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy. Receives: Drug: Granisetron and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Complete response rate during the first cycle defined as no emetic episodes, no rescue medication use during the first cycle of HAIC therapy.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aprepitant in combination with Granisetron and dexamethasone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Le-Qun Li, Study chair, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711823
- Sponsor's protocol ID
- ARGUE
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available on request due to privacy/ethical restrictions.
Publications
Zhao Y, He M, Liang R, Li Q, Shi M. Evaluation of Antiemetic Therapy for Hepatic Arterial Infusion Chemotherapy with Oxaliplatin, Fluorouracil, and Leucovorin. Ther Clin Risk Manag. 2021 Jan 22;17:73-77. doi: 10.2147/TCRM.S283192. eCollection 2021.
PubMed 33519205Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.
PubMed 27664248
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ApRepitant in Combination With Granisetron and Dexamethasone versUs Granisetron and dexamEthasone for the Prevention of Vomiting in Patients With HAIC Therapy for Hepatocellular Carcinoma: a Randomized Controlled Study (ARGUE)
- ClinicalTrials.gov ID
- NCT05711823
- Acronym / sponsor ID
- ARGUE
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and efficacy of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in the prevention of nausea and vomiting in patients with hepatocellular carcinoma (HCC) receiving hepatic arterial infusion chemotherapy (HAIC).
Detailed description
FOLFOX regimen include oxaliplatin and 5-Fu. Oxaliplatin has a moderate emetic potential and 5-Fu has a low emetic potential according to European guideline for the prevention of nausea and vomiting caused by chemotherapy and radiotherapy. The Guideline recommend that patients receiving moderately emetogenic chemotherapy receive a three-drug regimen of 5-HT3, dexamethasone, and NK1-RA (aprepitant, fosaprepitant, netupitant or rolapitant). However, HAIC treatment is not through peripheral or central venous infusion of chemotherapy drugs as in other cancers, but through hepatic artery infusion of chemotherapy drugs. Chemotherapy drugs are mainly concentrated in the liver and belong to local chemotherapy, rather than systemic chemotherapy through the venous system. Therefore, although the HAIC regimen includes oxaliplatin and 5-Fu, two chemotherapeutic drugs that may cause vomiting, the literature on whether three-drug regimen is also needed to prevent vomiting has been less publicly reported. In order to further determine whether three-drug regimen is necessary, this project intends to conduct a multi-center, randomized, controlled trial to evaluate the efficacy and safety of aprepitant combined with granisetron and dexamethasone versus granisetron and dexamethasone in preventing nausea and vomiting in HCC patients receiving HAIC treatment. The results of this project will provide a reference for improving the quality of life of HCC patients during HAIC treatment, the compliance of follow-up treatment and saving medical resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Aprepitant in combination with Granisetron and dexamethasone
| Arm | Type | Receives |
|---|---|---|
| Aprepitant in combination with granisetron and dexamethasone | Experimental | Drug: Aprepitant in combination with granisetron and dexamethasonePatients with unresectable hepatocellular carcinoma will receive aprepitant in combination with granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy. |
| granisetron and dexamethasone | Active comparator | Drug: Granisetron and dexamethasonePatients with unresectable hepatocellular carcinoma will receive granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-75 years old;
- The patient is diagnosed with hepatocellular carcinoma according to the clinical diagnostic criteria of the Guideline for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) issued by the Health Commission of the People's Republic of China or confirmed by histopathology;
- ECOG performance score 0 or 1;
- Child-Pugh score of 5-7 (liver function);
- Receiving hepatic arterial infusion chemotherapy treatment;
Key exclusion criteria (9 listed)
- Received systematic chemotherapy in the past;
- The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);
- Active infection, or body temperature ≥ 38.5℃ or white blood cell count > 15 x 10^9/L 7 days before enrollment;
- Complications of arterial or venous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary infarction, etc. within 6 months;
- Those who have a history of alcohol or psychotropic drug abuse and cannot quit or have mental disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprepitant in combination with granisetron and dexamethasonePatients with unresectable hepatocellular carcinoma will receive aprepitant in combination with granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy. | Drug | Aprepitant in combination with granisetron and dexamethasone |
| Granisetron and dexamethasonePatients with unresectable hepatocellular carcinoma will receive granisetron and dexamethasone during the therapeutic process of hepatic arterial infusion chemotherapy. | Drug | granisetron and dexamethasone |
Primary outcome
Complete response rate
Time frame: 3 weeks
Complete response rate during the first cycle defined as no emetic episodes, no rescue medication use during the first cycle of HAIC therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 33519205Zhao Y, He M, Liang R, Li Q, Shi M. Evaluation of Antiemetic Therapy for Hepatic Arterial Infusion Chemotherapy with Oxaliplatin, Fluorouracil, and Leucovorin. Ther Clin Risk Manag. 2021 Jan 22;17:73-77. doi: 10.2147/TCRM.S283192. eCollection 2021.
- Background: PubMed 27664248Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.
- Individual participant dataSharing planned: No. Data available on request due to privacy/ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Le-Qun Li study chair
Guangxi Medical University Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant in combination with granisetron and dexamethasone and Granisetron and dexamethasone in people with Hepatocellular Carcinoma, run by Guangxi Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Hong Zhong, Ph.D (+86 771 5301253, zhongjianhong66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.